DGFT Committee Minutes

Office of Directorate General of Foreign Trade  New Delhi  ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Para 4.7 Decision MEETING NUMBER : 38/82­ALC4/2011 MEETING DATE : 20.12.2011 The Meeting No.38/82 in the year 2011­12 to consider the cases under Duty Exemption Scheme (Chapter­4) of Foreign Trade Policy, 2009­14 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 20.12.2012 was actually held on 22.12.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber.   Following members were present:­ 1.       Shri Pramod Bharti, Asstt. Director, DC(MSME) 2.      Shri Jasbir Singh, Consultant, Department of C&PC 3.      Shri D.N. Mathur, Consultant, Department of Pharmaceuticals 4.      Ms.Lalita Maini, FTDO   At the outset, minutes of Norms Committee Meeting No.37/82 dated 13.12.2011  were ratified by the Committee.   Case No.B­409 M/S Herbochem Limited Norms Committee Meeting No.38/AM12 F.No.01/82/050/00140/AM12/DES­III Meeting Date:22.12.2012 RA F.No.09/24/040/00469/AM11   Adv.lic.No.0910045206 dated 19.01.11     Committee considered case as per agenda and decided to call from the firm production and consumption data certified by Central Excise authority.  Accordingly case was deferred for  24.01.2012.     Case No.B­410     M/S Chiral Bioscience Limited Norms Committee Meeting No.38/AM12 F.No.01/82/050/01656/AM12/DES­III F.No. 01/82/50/00108/AM11/DES­III Meeting Date:22.12.2012 RA F.No.09/24/040/00329/AM11 RA F.No 09/24/40/00203/AM10   Adv.lic.No.0910044574 dated 06.12.10 Adv.LicNo.0910039636 dated 16.10.09     Committee  considered  case  as  per  agenda  and    decided  to  defer  the  case  for  24.01.2012  for  comments  of Department of Pharmaceuticals.         Case No.B­411     M/S Laffans Petrochemicals Ltd. Norms Committee Meeting No.38/AM12 F.No.01/82/050/00654/AM12/DES­III

Meeting Date:22.12.2012 RA F.No.03/95/40/00111/AM08   Adv.lic.No.0310433500 dated  22.06.2007     Committee considered case as per agenda. The Committee decided to seek actual value of imports and exports (both quantity and value) from the firm as the value addition is very low.  The case was deferred for 24.01.2012.         Case No.A­55     M/S Watson Pharma Pvt. Ltd., Goa Norms Committee Meeting No.38/AM12 F.No.01/82/162/00768/AM11/DES­III F.No. 01/82/162/00772/AM11/DES­III F.No 01/82/162/00776/AM11/DES III F.No 01/82/162/00777/AM11/DES­III F.No 01/82/162/00769/AM11/DES­III F.No. 01/82/162/00775/AM11/DES­III F.No. 01/82/162/00770/AM11/DES­III F.No. 01/82/162/00773/AM11/DES­III F.No. 01/82/162/00774/AM11/DES­III Meeting Date:22.12.2012     Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of Pharmaceuticals  vide  their  O.M.  No.35011/225/2010­PI­(Norms)  dated  25.11.2011,  and  in  consultation  with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:­ Export product Export Qty. Sl.No. Import items Qty. allowed 1000 No. of Capsules         10mg 25mg 50mg 75mg Nortriptyline Capsules  HCL 10  Mg/25 Mg/50  MG/75 MG 1000  No. of Capsules 1. NORTRIPTYLINE HCL USP 11.614 29.034 58.069 87.103 2. PREGELATINISED STARCH 215.705 364.817 330.180 308.45 3. COLLOIDAL SILICA QUANTITY NOT APPLIED       4. SODIUM LAURYL SULFATE 0.946 1.910 1.892 1.922       MAGNESIUM STEARATE VEGETABLE GRADE 1.892 3.820 3.784 3.844       EHG CAPS ‘3’ GRN/WHT NORTRPTLINE 10 USP RELEVANT, AS PER PACKING POLICY

Export product Export Qty. S.No Import Item Quantity Allowed     For  1000  tablets  (Quantity  in gms.) Carisoprodol 350  MG USP 1000 tablets/capsules of 350 mg 1. CARISOPRODOL USP 357     2. STARCH UNIPURE FL NF 55.789     3. POVIDONE PLASDONE K29/32USP 14.66     4. ANHYDROUS LACTOSE D.T NF 18.569     5. SODIUM STARCH GLYCOLATE USP NF 11.728     6. DOCUSATE NA 85% & 15% NA BENZOATE NF (GRN) 1.955     7. MAGNESIUM  STEARATE  VEGETABLE  GRADE NF 1.955     Export Product Export Qty. S.No Import Item Quantity Recommended   For Export of 1000 nos. tablets  (Quantity in gms.)         2.5 MG 30 MG Lisinopril 2.5 MG  &  30 MG 1000  tablets/capsules 2.5 Mg & 30 Mg 1.         LISINOPRIL USP 2.55 30.60     2.         DIBASIC  CA  PHOSP DIHYDRATE UNMILLED USP 53.89 183.0     3.         MANNITOL  PEARLITOL  SD 200 USP 30.24 119.58     4.         PREGELATINISED  STARCH 1500 NF 11.706 48.216     5.         FD  &  C  YELLOW  #  5 ALUMINIUM LAKE 0.976 3.857     6.         COLLOIDAL  SILICON DIOXIDE AEROSIL 200  NF 0.976 3.857     7.         MAGNESIUM  STEARATE VEGETABLE GRADE NF NIL 0.964     Export Product Export Qty. S.No Import Item Quantity Recommended   For  EXPORT  OF  1000  Nos.  tablets (Quantity in gms.) Methocarbamol  500 MG & 750 MG 1000 tables/capsules  of 500 mg & 750 mg     500  mg 750 mg     1 METHOCARBAMOL USP 510.0 765.0     2 PREGELATINISED  STARCH 1500 NF 20.408 30.138     3 SODIUM  STARCH GLYCOLATE USP NF 8.75 12.638     4 COLLOIDAL  SIO2  CAB­O­ SILNF QTY.  NOT APPLIED       5 STEARIC ACID NF 2.915 4.861     6 MAGNESIUM  STEARATE 1.944 2.917

VEGETABLE GRADE NF   RA concerned may take further necessary action as per above decision of NC.          Case No.a­88     M/S Alkem Laboratories Limited, Mumbai Norms Committee Meeting No.38/AM12 F.No.01/82/162/01131/AM11/DES­III   Meeting Date:22.12.2012   Committee considered case as per agenda and decided to call the firm for  personal hearing on 10.1.2012.  The case is deferred for 24.01.2012.       1 Case No.:51/41/82­ALC4/2010 Party Name:MATRIX LABORATORIES LTD Meet No/Date:38/82­ALC4/2011 20.12.2011 Status:Case Approved HQ File :01/82/050/01399/AM11/ RLA File :09/24/040/00091/AM11/ Lic.No/Date:0910042508 25.06.2010 22.10.2011 Decision :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  O.M. No.35011/05/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:­   Export Product Exp. Qty. S.No Import Item Qty. allowed Ezetimibe 140000 Kg 1. 5­(4­FLURO PHENYL)­5­OXO­ PENTANOIC ACID 1.87Kg     2. TRIETHYLAMINE 4.985 Kg     3. MORPHOLINE 1.06 Kg     4. SODIUM BORO HYDRIDE 0.19 Kg     5. IMMOZYME CANDIDA ANTARCTICA LIPASE A (IMMCALA­T2­150) 0.205 Kg     6. VINYL ACETATE 1.33 Kg     7. S­4­PHENYLOXA ZOLIDINONE 0.93 Kg     8. DIMETHYL AMINO PYRIDINE 0.09 Kg     9. 4­BENXYLOXYBENZYL IDINE­4­ FLUOROANILINE 0.60 Kg     10. TETRA HYDRO FURAN 3.54Kg     11. METHANOL 13.53     12. N­HEPTANE 11.25

CITRIC ACID 0.193     2 Case No.:2/43/82­ALC4/2010 20.12.2011 Status:Case Approved HQ File :01/82/050/01465/AM11/ RLA File :09/24/040/00090/AM11/ Lic.No/Date:0910042511 25.06.2010 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/227/2010­PI­(Norms) dated 15.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of     Export Product Exp. Qty. S.No Import Item Qty. allowed kg/kg Voriconazone 3000 Kg. 1. 4­CHLORO­6­ETHYL­5­FLUORO­ PYRIMIDINE 4.80     2. 1­(2,4­DIFLUORO PHENCYL)­2­(1H­ 1,2,3­TRIAZOLE­1­YL)ETHANONE 9.98     3. R(­)10 CAMPHOR SULFONIC  ACID 1.63     4. TETRA HYDRO FURAN 14.64     5. ACETONE 5.11     6. METHANOL 2.49     3 Case No.:18/47/82­ALC4/2010 20.12.2011 Status:Case Approved HQ File :01/82/050/01608/AM11/ RLA File :09/24/040/00505/AM10/ Lic.No/Date:0910042504 25.06.2010 22.11.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/43/2011­PI­(Norms) dated 7.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:­   Export Product Exp. Qty. S.No Import Item Qty. allowed kg/kg Nadolol 8000kg. 1. 5,6,7,8­TETRAHYDRO NAPHTHALENE­1,6,7­TRIOL 1.264     2. 2,2­DIMETHOXY PROPANE 3.30

METHANOL 5.00     4. ACETONE 3.18     5. METHYLENE CHLORIDE 8.64     4 Case No.:12/15/82­ALC4/2010 Party Name:MEDREICH LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:24.01.2012 Decision :  Committee decided to call from the firm Master Batch Formula certified by their Quality Control Incharge.  Accordingly, case was deferred for 24.01.2012.   5 Case No.:63/39/82­ALC4/2010 20.12.2011 Status:Case Deferred HQ File :01/82/050/01144/AM11/ RLA File :09/24/040/00116/AM11/ Lic.No/Date:0910042624 06.07.2010 Defer Date:24.01.2012 Decision :  The Committee deferred the case for 24.01.2012.   6 Case No.:71/39/82­ALC4/2010 20.12.2011 Status:Case Approved HQ File :01/82/050/01152/AM11/ RLA File :09/24/040/00008/AM11/ Lic.No/Date:0910042622 06.07.2010 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/227/2010­PI­(Norms) dated 15.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of     Export Product Exp. Qty. S.No Import Item Qty. allowed kg/kg [1(S)­BENZYL­ 2(R), 3­ EPOXYPROPYL]­ CARBAMIC ACID­ TERT­ BUTYLESTER­ (2R­EPOXIDE) 15000Kg 1. (1S,2R) [N­(TERT­BUTOXY CARBONYL)L­ PHENYLALANINE)CHLOROHYDRINE 1.25     2. ISO PROPYL ALCOHOL 0.857

  7 Case No.:122/40/82­ALC4/2010 Party Name:SURYA PHARMACEUTICAL LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/01321/AM11/ RLA File :22/24/040/00025/AM11/ Lic.No/Date:2210010236 03.08.2010 Defer Date:24.01.2012 Decision :  The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals.   8 Case No.:56/41/82­ALC4/2010 Party Name:LUPIN LIMITED 20.12.2011 Status:Case Approved HQ File :01/82/050/01404/AM11/ RLA File :03/95/040/00392/AM11/ Lic.No/Date:0310589566 26.08.2010 22.12.2011 Decision :  The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals.   9 Case No.:10/28/82­ALC4/2010 Party Name:VIVIMED LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals   10 Case No.:6/30/82­ALC4/2010 Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00925/AM11/ RLA File :03/94/040/00472/AM11/ Lic.No/Date:0310595543 06.10.2010 Defer Date:24.01.2012 Decision :  Committee considered case as per agenda and in the light of written comments forwarded by . Department of Pharmaceuticals vide their O.M. No.35011/34/2011­PI­(Norms) dated 8.12.2011, decided to call the following technical details from the firm:   Stepwise chemical reaction showing MoI.  Wt. of each input & output product. % yield on molar basis for each step. Certificate of Analysis for Benzil (Tech.) from the foreign supplier. Copy of technical literature in support of yield claimed. Production­consumption data duly certified by Central Excise Authorization.   11 Case No.:41/40/82­ALC4/2010 Party Name:LUPIN LIMITED 20.12.2011 Status:Case Approved HQ File :01/82/050/01240/AM11/ RLA File :03/95/040/00522/AM11/ Lic.No/Date:0310598693 Defer Date:

26.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/08/2010­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of   Export Product Exp. Qty. S.No Import Item Qty. allowed STERILE CEFTRIAXONE SODIUM (Non­ Infringing) (STERILE CEFTRIAXONE SODIUM 275 mg/250 mg) 3000 kg 1. ETHYL ACETATE 2.181kg/kg of Sterile Ceftriaxone Sodium     2. METHYLENE CHLORIDE 2.00kg/kg of Sterile Ceftriaxone Sodium     3. SODIUM HYDROSULPHITE 0.0049 kg/kg of Sterile Ceftriaxone Sodium     4. 7 AMINO CEPHALOSPORANIC ACID 0.668 kg/kg of Sterile Ceftriaxone Sodium     5. 2,5,DIHYDRO­6­HYDROXY­3­ MERCAPTO­2­METHYL­5­OXO­ 1,2,4­TRIAZENE 0.360 kg/kg of Sterile Ceftriaxone Sodium     6. BORON TRIFLUORIDE GAS 0.611 kg/kg of Sterile Ceftriaxone Sodium     7. ACETONITRILE 2.60 kg/kg of Sterile Ceftriaxone Sodium     8. ACETONE 11.50 kg/kg of Sterile Ceftriaxone Sodium

ACTIVATED CARBON 0.100 kg/kg of Sterile Ceftriaxone Sodium     10. TETRA HYDROFURAN 1.23 kg/kg of Sterile Ceftriaxone Sodium     11. FORMIC ACID 3.158 kg/kg of Sterile Ceftriaxone Sodium     12. HEXAMETHYL DISILAZANE 0.540 kg/kg of Sterile Ceftriaxone Sodium     13. TRIETHYL AMINE 0.514 kg/kg of Sterile Ceftriaxone Sodium     14. PHOSPHOROUS PENTACHLORIDE 0.474 kg/kg of Sterile Ceftriaxone Sodium     15. ISOPROPYL ALCOHOL 0.400 kg/kg of Sterile Ceftriaxone Sodium     16. THIOUREA 0.180 kg/kg of Sterile Ceftriaxone Sodium     17. ETHYLENE DIAMINE  TETRA ACETIC ACID DISODIUM SALT (E.D.T.A DI SODIM) 0.040 kg/kg of Sterile Ceftriaxone Sodium     18. SODIUM BICARBONATE 0.511 kg/kg of Sterile Ceftriaxone Sodium

TRIMETHYL CHLOROSILANE 0.079 kg/kg of Sterile Ceftriaxone Sodium     20. SODIUM 2­ETHYL HEXANOATE 0.684 kg/kg of Sterile Ceftriaxone Sodium     21. 4­BROMO­2­METHOXYIMINO­3­ OXO BUTYRIC ACID (BROMO ACID) 0.485 kg/kg of Sterile Ceftriaxone Sodium     12 Case No.:53/40/82­ALC4/2010 20.12.2011 Status:Case Deferred HQ File :01/82/050/01252/AM11/ RLA File :09/24/040/00281/AM11/ Lic.No/Date:0910044023 26.10.2010 Defer Date:24.01.2012 Decision :  The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals.   13 Case No.:56/40/82­ALC4/2010 20.12.2011 Status:Deffered and Re­indexed HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:20.12.2011 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals.   14 Case No.:12/32/82­ALC4/2010 20.12.2011 Status:Case Deferred HQ File :01/82/050/00994/AM11/ RLA File :09/24/040/00300/AM11/ Lic.No/Date:0910044098 02.11.2010 Defer Date:24.01.2012   15 Case No.:44/40/82­ALC4/2010 Party Name:LUPIN LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Defer Date:24.01.2012

  16 Case No.:3/35/82­ALC4/2010 Party Name:SOFTGEL HEALTH CARE PVT. LTD., 20.12.2011 Status:Case Deferred HQ File :01/82/050/01019/AM11/ RLA File :04/24/040/00215/AM11/ Lic.No/Date:0410118914 16.11.2010 Defer Date:24.01.2012   17 Case No.:17/35/82­ALC4/2010 Party Name:ALEMBIC LIMITED 20.12.2011 Status:Case Approved HQ File :01/82/050/01033/AM11/ RLA File :34/24/040/00216/AM11/ Lic.No/Date:3410028617 22.11.2010 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/14/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of Export Product Exp. Qty. S.NO IMPORT ITEM Qty. allowed kg/kg SILYL ESTER (2,4­O­ TRIMETHYLSILYL)­ ERYTHROMYCIN­A­ 9(1­METHOXY­1­ METHYL ETHYL)OXIME] 500000 Kg 1. ERYTHROMYCIN THIOCYANATE 0.86     2. HYDROXYLAMINE HYDROCHLORIDE 0.377     3. METHANOL 2.907     4. METHYLENE CHLORIDE 7.03     5. 2­METHOXY PROPENE 0.233     6. HEXAMETHYL DISILIZANE 0.261     18 Case No.:25/40/82­ALC4/2010 20.12.2011 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:24.01.2012   19 Case No.:6/43/82­ALC4/2010 Party Name:ASTRIX LABORATORIES LTD., Status:Case

20.12.2011 Approved HQ File :01/82/050/01469/AM11/ RLA File :09/24/040/00292/AM11/ Lic.No/Date:0910044462 25.11.2010 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/11/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of Export Product Export Qty. S.No Import Item Qty. allowed kg/kg NEVIRAPINE (NITRO COMPOUND ROUTE) 1000 kg 1. 2­Chloro­4­methyl­3­nitro pyridine 1.011     2. Triethyl amine 0.607     3. Tetrahydrofuran 2.00     4. 2­Chloro nicotinic acid 0.902     5. Cyclopropylamine 0.57     6. N,N­Dimethyl Formamide 0.292     20 Case No.:19/47/82­ALC4/2010 Party Name:ASTRIX LABORATORIES LTD., 20.12.2011 Status:Case Approved HQ File :01/82/050/01609/AM11/ RLA File :09/24/040/00291/AM11/ Lic.No/Date:0910044461 25.11.2010 Defer Date: Decision :  Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/11/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of HBP   Export Product Export Qty. S.No Import Item Qty. allowed kg/kg NEVIRAPINE (CARBOXAMIDE ROUTE) 1000 kg 1. 2­Chloro­N­(2­chloro­4­methyl­ 3­pyridinyl)­3­ pyridineCarboxamide (Carboxamide) 1.428     2. Cyclopropylamine 0.57     3. Methanol 1.082     4. N,N­Dimethyl Formamide 0.292     21 Case No.:28/46/82­ALC4/2010 Party Name:VIVIMED LABS LIMITED Status:Case

20.12.2011 Deferred HQ File :01/82/050/01583/AM11/ RLA File :09/24/040/00295/AM11/ Lic.No/Date:0910044520 01.12.2010 Defer Date:24.01.2012   22 Case No.:11/40/82­ALC4/2010 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.12.2011 Status:Case Deferred HQ File :01/82/050/01210/AM11/ RLA File :05/23/040/00250/AM11/ Lic.No/Date:0510279466 15.12.2010 Defer Date:24.01.2012   23 Case No.:30/41/82­ALC4/2010 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.12.2011 Status:Case Deferred HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:24.01.2012   24 Case No.:14/51/82­ALC4/2010 Party Name:TITAN LABORATORIES PVT. LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:24.01.2012   25 Case No.:5/44/82­ALC4/2010 Party Name:RANBAXY LABORATORIES LTD 20.12.2011 Status:Case Approved HQ File :01/82/050/01504/AM11/ RLA File :05/24/040/00342/AM11/ Lic.No/Date:0510281982 19.01.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/35/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty S.No Import Item Qty. Recommended kg/kg VALSARTAN 15000 Kg 1. 2­CYANO­4­BROMOMETHYL BIPHENYL 1.274     2. ACETONE 3.94     3. ACTIVATED CARBON 0.100     4. DIISOPROPYL ETHER 2.66     5. L­VALINE 0.708

METHANOL 3.15     7. METHYLENE CHLORIDE 3.60     8. N­PENTANE 5.12     9. PALLADIUM SPONGE 3.16 GM/KG     10. TOLUENE 4.03 KG/KG     26 Case No.:23/6/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:24.01.2012   27 Case No.:31/47/82­ALC4/2010 Party Name:VIVIMED LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/01621/AM11/ RLA File :09/24/040/00510/AM11/ Lic.No/Date:0910045498 09.02.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC.   28 Case No.:36/47/82­ALC4/2010 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/01626/AM11/ RLA File :09/24/040/00509/AM11/ Lic.No/Date:0910045516 11.02.2011 Defer Date:24.01.2012   29 Case No.:40/47/82­ALC4/2010 Party Name:PERKIN LABORATORIES 20.12.2011 Status:Case Approved HQ File :01/82/050/01630/AM11/ RLA File :09/24/040/00460/AM10/ Lic.No/Date:0910045524 11.02.2011 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/70/2011­PI­(Norms) dated 8.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP Export Product Export Qty. S.No Import Item Qty. allowed kg/kg BROMO KETOROLAC 1000 Kg 1. PYRROLE 1.0064     2. ISOPROPENYL ACETATE 0.90

DIMETHYL SULPHOXIDE 2.24     4. DMF 2.00     5. POTASSIUM CARBONATE 5.44     6. DI­ETHYL MALONATE 3.00     30 Case No.:53/47/82­ALC4/2010 Party Name:NEULAND LABORATORIES LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:24.01.2012   31 Case No.:11/8/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00211/AM12/ RLA File :09/24/040/00499/AM11/ Lic.No/Date:0910045601 18.02.2011 Defer Date:24.01.2012   32 Case No.:32/51/82­ALC4/2010 Party Name:PERKIN LABORATORIES 20.12.2011 Status:Case Approved HQ File :01/82/050/01749/AM11/ RLA File :09/24/040/00251/AM11/ Lic.No/Date:0910045763 03.03.2011 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/70/2011­PI­(Norms) dated 8.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP   Export Product Export Qty. S.No Import Item Qty. allowed kg/kg BROMO KETOROLAC 1000 kg 1. PYRROLE 1.0064     2. ISOPROPENYL ACETATE 0.90     3. DIMETHYL SULPHOXIDE 2.24     4. DMF 2.00     5. POTASSIUM CARBONATE 5.44     6. DI­ETHYL MALONATE 3.00  

33 Case No.:33/51/82­ALC4/2010 Party Name:PERKIN LABORATORIES 20.12.2011 Status:Case Approved HQ File :01/82/050/01750/AM11/ RLA File :09/24/040/00541/AM11/ Lic.No/Date:0910045764 03.03.2011 22.12.2011 Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/70/2011­PI­(Norms) dated 8.12.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of HBP  :   Export Product Export Qty. S.No Import Item Qty. allowed kg/kg BROMO KETOROLAC 1000 kg 1. PYRROLE 1.0064     2. ISOPROPENYL ACETATE 0.90     3. DIMETHYL SULPHOXIDE 2.24     4. DMF 2.00     5. POTASSIUM CARBONATE 5.44     6. DI­ETHYL MALONATE 3.00     34 Case No.:34/51/82­ALC4/2010 Party Name:PERKIN LABORATORIES 20.12.2011 Status:Case Approved HQ File :01/82/050/01751/AM11/ RLA File :09/24/040/00503/AM11/ Lic.No/Date:0910045771 03.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/69/2011­PI­(Norms) dated 8.12.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of HBP  :   Export Product Export Qty. S.No Import Item Qty. allowed kg/kg DIBENZO­[B,F] [1,4]THIAZEPINE­ 11 [10H]­ONE 2000 Kg 1. THIOPHENOL 0.68     2. PHENYL 1.062

CHLOROFORMATE     3. POLY PHOSPHORIC ACID 5.10     4. ACETONE 0.52     35 Case No.:36/51/82­ALC4/2010 Party Name:PERKIN LABORATORIES 20.12.2011 Status:Case Approved HQ File :01/82/050/01753/AM11/ RLA File :09/24/040/00449/AM11/ Lic.No/Date:0910045776 03.03.2011 22.12.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/69/2011­PI­(Norms) dated 8.12.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of HBP  :   Export Product Export Qty. S.No Import Item Qty. allowed kg/kg DIBENZO­[B,F] [1,4]THIAZEPINE­ 11 [10H]­ONE 2000 Kg 1. THIOPHENOL 0.68     2. PHENYL CHLOROFORMATE 1.062     3. POLY PHOSPHORIC ACID 5.10     4. ACETONE 0.52     36 Case No.:43/51/82­ALC4/2010 Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 20.12.2011 Status:Deffered and Re­indexed HQ File :01/82/050/01760/AM11/ RLA File :09/24/040/00539/AM11/ Lic.No/Date:0910045802 04.03.2011 Defer Date:24..01.2012   37 Case No.:52/51/82­ALC4/2010 Party Name:IPCA LABORATORIES LIMITED 20.12.2011 Status:Case Approved HQ File :01/82/050/01769/AM11/ RLA File :03/94/040/01002/AM11/ Lic.No/Date:0310620013 08.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/58/2011­PI­(Norms) dated 7.12.2011, and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP

No.35011/58/2011 PI (Norms) dated 7.12.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP Export Product Export Qty S.No Import Item Qty. allowed kg/kg TESTOSTERONE PHENYL PROPIONATE 50 Kg 1. 4­ANDROSTENE­3,17­ DIONE 0.974     38 Case No.:16/10/82­ALC4/2011 Party Name:VASUDHA PHARMA CHEM LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00275/AM12/ RLA File :09/24/040/00327/AM11/ Lic.No/Date:0910045893 11.03.2011 Defer Date:24.01.2012   39 Case No.:17/10/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00276/AM12/ RLA File :09/24/040/00521/AM11/ Lic.No/Date:0910045939 16.03.2011 Defer Date:24.01.2012   40 Case No.:21/10/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00280/AM12/ RLA File :09/24/040/00500/AM11/ Lic.No/Date:0910045938 16.03.2011 Defer Date:24.01.2012   41 Case No.:5/2/82­ALC4/2011 Party Name:SMRUTHI ORGANICS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/01795/AM11/ RLA File :31/24/040/00281/AM11/ Lic.No/Date:3110047488 22.03.2011 Defer Date:24.01.2012   42 Case No.:15/2/82­ALC4/2011 Party Name:VIJETA LIFE SCIENCES PVT LTD., 20.12.2011 Status:Case Deferred HQ File :01/82/050/01805/AM11/ RLA File :09/24/040/00571/AM11/ Lic.No/Date:0910046087 25.03.2011 Defer Date:24.01.2012

  43 Case No.:18/4/82­ALC4/2011 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.12.2011 Status:Case Deferred HQ File :01/82/050/00069/AM12/ RLA File :05/23/040/00380/AM11/ Lic.No/Date:0510287716 07.04.2011 Defer Date:24.01.2012   44 Case No.:19/4/82­ALC4/2011 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.12.2011 Status:Case Deferred HQ File :01/82/050/00070/AM12/ RLA File :05/23/040/00381/AM11/ Lic.No/Date:0510287719 07.04.2011 Defer Date:24.01.2012   45 Case No.:32/8/82­ALC4/2011 Party Name:ENCUBE ETHICALS PVT LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00232/AM12/ RLA File :03/94/040/01167/AM11/ Lic.No/Date:0310625603 07.04.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of DC(MSME).   46 Case No.:41/8/82­ALC4/2011 Party Name:ENCUBE ETHICALS PVT LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00241/AM12/ RLA File :03/94/040/01171/AM11/ Lic.No/Date:0310625608 07.04.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of DC(MSME).   47 Case No.:48/4/82­ALC4/2011 Party Name:VIVIMED LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00099/AM12/ RLA File :09/24/040/00003/AM12/ Lic.No/Date:0910046368 12.04.2011 Defer Date:24.01.2012   48 Case No.:15/12/82­ALC4/2011 Party Name:ENCUBE ETHICALS PVT LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00348/AM12/ RLA File :03/94/040/00052/AM12/ Lic.No/Date:0310627904 Defer

25.04.2011 Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of DC(MSME).   49 Case No.:44/6/82­ALC4/2011 Party Name:SUVEN LIFE SCIENCES LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00163/AM12/ RLA File :09/24/040/00038/AM12/ Lic.No/Date:0910046559 28.04.2011 Defer Date:24.01.2012   50 Case No.:4/8/82­ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00204/AM12/ RLA File :09/24/040/00606/AM11/ Lic.No/Date:0910046587 02.05.2011 Defer Date:24.01.2012   51 Case No.:6/8/82­ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:24.01.2012   52 Case No.:3/8/82­ALC4/2011 Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:38/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00203/AM12/ RLA File :03/95/040/00084/AM12/ Lic.No/Date:0310629782 05.05.2011 Defer Date:24.01.2012   53 Case No.:9/14/82­ALC4/2011 Party Name:IPCA LABORATORIES LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00400/AM12/ RLA File :03/94/040/00091/AM12/ Lic.No/Date:0310629729 05.05.2011 Defer Date:24.01.2012   54 Case No.:15/16/82­ALC4/2011 Party Name:RA CHEM PHARMA LIMITED 20.12.2011 Status:Case Deferred

HQ File :01/82/050/00473/AM12/ RLA File :09/24/040/00035/AM12/ Lic.No/Date:0910046677 09.05.2011 Defer Date:24.01.2012   55 Case No.:42/8/82­ALC4/2011 Party Name:FRESENIUS KABI ONCOLOGY LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00242/AM12/ RLA File :05/23/040/00366/AM11/ Lic.No/Date:0510290205 10.05.2011 Defer Date:24.01.2012   56 Case No.:5/12/82­ALC4/2011 Party Name:LUPIN LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00338/AM12/ RLA File :03/95/040/00067/AM12/ Lic.No/Date:0310630428 10.05.2011 Defer Date:24.01.2012   57 Case No.:31/14/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00422/AM12/ RLA File :09/24/040/00023/AM12/ Lic.No/Date:0910046786 19.05.2011 Defer Date:24.01.2012   58 Case No.:5/10/82­ALC4/2011 Party Name:HETERO LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00264/AM12/ RLA File :09/24/040/00087/AM12/ Lic.No/Date:0910046811 20.05.2011 Defer Date:24.01.2012   59 Case No.:41/10/82­ALC4/2011 Party Name:HETERO LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00300/AM12/ RLA File :09/24/040/00111/AM12/ Lic.No/Date:0910046916 26.05.2011 Defer Date:24.01.2012   60 Case No.:51/10/82­ALC4/2011 Party Name:SATYA DEEPTHA Status:Case

PHARMACEUTICALS LTD 20.12.2011 Deferred HQ File :01/82/050/00310/AM12/ RLA File :09/24/040/00095/AM12/ Lic.No/Date:0910046934 27.05.2011 Defer Date:24.01.2012   61 Case No.:1/14/82­ALC4/2011 Party Name:STERLING AUXILIARIES PVT LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00392/AM12/ RLA File :03/95/040/00138/AM12/ Lic.No/Date:0310633159 27.05.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department Chemicals and Petrochemicals.   62 Case No.:14/11/82­ALC4/2011 Party Name:HETERO DRUGS LIMITED, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00328/AM12/ RLA File :09/24/040/00106/AM12/ Lic.No/Date:0910046965 01.06.2011 Defer Date:24.01.2012   63 Case No.:38/12/82­ALC4/2011 Party Name:SRINI PHARMACEUTICALS LTD., 20.12.2011 Status:Case Deferred HQ File :01/82/050/00371/AM12/ RLA File :09/24/040/00113/AM12/ Lic.No/Date:0910046991 03.06.2011 Defer Date:24.01.2012   64 Case No.:34/12/82­ALC4/2011 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00367/AM12/ RLA File :03/94/040/01112/AM11/ Lic.No/Date:0310634571 06.06.2011 Defer Date:24.01.2012   65 Case No.:6/18/82­ALC4/2011 Party Name:VIVIMED LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00510/AM12/ RLA File :09/24/040/00094/AM12/ Lic.No/Date:0910047017 06.06.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of Chemicals & Petrochemicals.

66 Case No.:10/19/82­ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00524/AM12/ RLA File :09/24/040/00128/AM12/ Lic.No/Date:0910047036 07.06.2011 Defer Date:24.01.2012   67 Case No.:4/16/82­ALC4/2011 Party Name:BOSTIK INDIA PRIVATE LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC(Petrochemicals).   68 Case No.:21/19/82­ALC4/2011 Party Name:VIVIMED LABS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00535/AM12/ RLA File :09/24/040/00138/AM12/ Lic.No/Date:0910047112 14.06.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC.   69 Case No.:23/19/82­ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00537/AM12/ RLA File :09/24/040/00105/AM12/ Lic.No/Date:0910047123 15.06.2011 Defer Date:24.01.2012   70 Case No.:24/19/82­ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00538/AM12/ RLA File :09/24/040/00125/AM12/ Lic.No/Date:0910047121 15.06.2011 Defer Date:24.01.2012   71 Case No.:14/16/82­ALC4/2011 Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 20.12.2011 Status:Case Approved HQ File :01/82/050/00472/AM12/ RLA File :05/24/040/00087/AM12/ Lic.No/Date:0510293897 20.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.

No.35011/48/2011­PI­(Norms) dated 7.12.2011, and in consultation with  technical authority present in meeting, decided to ratify norms under para 4.7 of HBP :   Export product Export Qty. S.No Import Item Qty. allowed kg/kg FEXOFENADINE INTERMEDIATE (FD3)/KETO ESTER 5000 Kg. 1. 2­METHYL­2­PHENYL PROPANOIC ACID 1.463     2. METHANOL 5.43     3. TOLUENE 4.44     4. METHYLENE CHLORIDE 1.83     5. DICYCLOHEXYLAMINE 0.75     72 Case No.:47/14/82­ALC4/2011 Party Name:FDC LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:24.01.2012 Decision :  The committee considered the case as per the agenda and decided to call information regarding percentage of API in the export product.  The case has been deferred for 24.1.2012.   73 Case No.:31/21/82­ALC4/2011 Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:38/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date:24.01.2012   74 Case No.:25/21/82­ALC4/2011 Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:38/82­ALC4/2011 20.12.2011 Status:Case Deferred HQ File :01/82/050/00607/AM12/ RLA File :09/24/040/00039/AM12/ Lic.No/Date:0910047386 30.06.2011 Defer Date:24.01.2012   75 Case No.:32/21/82­ALC4/2011 Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:38/82­ALC4/2011 20.12.2011 Status:Case Deferred

HQ File :01/82/050/00614/AM12/ RLA File :09/24/040/00041/AM12/ Lic.No/Date:0910047385 30.06.2011 Defer Date:24.01.2012   76 Case No.:16/20/82­ALC4/2011 Party Name:SAURAV CHEMICALS LTD, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00578/AM12/ RLA File :22/24/040/00024/AM12/ Lic.No/Date:2210011568 01.07.2011 Defer Date:24.01.2012   77 Case No.:34/16/82­ALC4/2011 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 20.12.2011 Status:Case Deferred HQ File :01/82/050/00492/AM12/ RLA File :03/95/040/01038/AM11/ Lic.No/Date:0310641073 07.07.2011 Defer Date:24.01.2012   78 Case No.:17/26/82­ALC4/2011 Party Name:CTX LIFESCIENCES PVT LTD, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00700/AM12/ RLA File :03/94/040/00302/AM12/ Lic.No/Date:0310642596 15.07.2011 Defer Date:24.01.2012   79 Case No.:11/26/82­ALC4/2011 Party Name:ARCH PHARMALABS LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00694/AM12/ RLA File :03/94/040/00317/AM12/ Lic.No/Date:0310642955 19.07.2011 Defer Date:24.01.2012   80 Case No.:4/26/82­ALC4/2011 Party Name:GALENTIC PHARMA (INDIA) PVT.LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00687/AM12/ RLA File :03/94/040/00352/AM12/ Lic.No/Date:0310643997 22.07.2011 Defer Date:24.01.2012 Decision : Committee decided to call from the firm Master Batch Formula certified by their Quality Control Incharge.  Accordingly, case was deferred for 24.01.2012.

81 Case No.:12/26/82­ALC4/2011 Party Name:CTX LIFESCIENCES PVT LTD,   20.12.2011 Status:Case Deferred HQ File :01/82/050/00695/AM12/ RLA File :03/94/040/00244/AM12/ Lic.No/Date:0310644247 25.07.2011 Defer Date:24.01.2012   82 Case No.:36/26/82­ALC4/2011 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00719/AM12/ RLA File :31/83/040/00084/AM12/ Lic.No/Date:3110049428 26.07.2011 Defer Date:24.01.2012 Decision  :  This case  was  considered  by  the  Committee  in  meeting  No.  36/82­ALC4/2011.  The  firm  has  been  requested  to  furnish  some details.  Requisite details have not been received from the firm.  Committee decided to remind the firm to furnish the required information. The Committee deferred the case for 24.01.2012.   83 Case No.:55/26/82­ALC4/2011 Party Name:TIDE INDUSTRIES 20.12.2011 Status:Case Deferred HQ File :01/82/050/00738/AM12/ RLA File :34/24/040/00075/AM12/ Lic.No/Date:3410031091 28.07.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012   84 Case No.:57/26/82­ALC4/2011 Party Name:ALEMBIC PHARMACEUTICALS LTD 20.12.2011 Status:Case Approved HQ File :01/82/050/00740/AM12/ RLA File :34/24/040/00083/AM12/ Lic.No/Date:3410031093 28.07.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/14/2011­PI­(Norms) dated 28.11.2011, and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of :   Export Product Export Qty. S.No Import Item Qty. recommended kg/kg SILYL ESTER (2,4­O­ BIS(TRIMETHYLSILYL)­ ERYTHROMYCIN­A­ 9[1­METHOXY­1­ METHYL ETHYL)OXIME] 50000 Kg. 1. ERYTHROMYCIN THIOCYANATE 0.86     2. HYDROXYLAMINE  HYDROCHLORIDE 0.377

METHANOL 2.907     4. METHYLENE CHLORIDE 7.03     5. 2­METHOXY PROPENE 0.233     6. HEXAMETHYL DISILIZANE 0.261   85 Case No.:25/26/82­ALC4/2011 Party Name:ENCUBE ETHICALS PVT LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of DC(MSME).   86 Case No.:50/26/82­ALC4/2011 Party Name:PAB ORGANICS PVT.LTD, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00733/AM12/ RLA File :34/24/040/00090/AM12/ Lic.No/Date:3410031224 08.08.2011 Defer Date:24.01.2012   87 Case No.:43/26/82­ALC4/2011 Party Name:NECTAR LIFESCIENCES LIMITED, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00726/AM12/ RLA File :22/24/040/00036/AM12/ Lic.No/Date:2210011760 09.08.2011 Defer Date:24.01.2012   88 Case No.:18/26/82­ALC4/2011 Party Name:CIPLA LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00701/AM12/ RLA File :03/94/040/00425/AM12/ Lic.No/Date:0310647629 10.08.2011 Defer Date:24.01.2012   89 Case No.:37/26/82­ALC4/2011 Party Name:R L FINE CHEM 20.12.2011 Status:Case Deferred HQ File :01/82/050/00720/AM12/ RLA File :07/24/040/00171/AM12/ Lic.No/Date:0710081348 10.08.2011 Defer Date:24.01.2012

p   90 Case No.:28/26/82­ALC4/2011 Party Name:INTAS PHARMACEUTICALS LTD., 20.12.2011 Status:Case Deferred HQ File :01/82/050/00711/AM12/ RLA File :08/24/040/00114/AM12/ Lic.No/Date:0810102412 11.08.2011 Defer Date:24.01.2012   91 Case No.:8/22/82­ALC4/2011 Party Name:PRASOL CHEMICALS LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00651/AM12/ RLA File :03/95/040/00154/AM12/ Lic.No/Date:0310649496 19.08.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC.   92 Case No.:9/22/82­ALC4/2011 Party Name:EMCURE PHARMACEUTICALS LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00652/AM12/ RLA File :31/83/040/00103/AM12/ Lic.No/Date:3110049873 19.08.2011 Defer Date:24.01.2012   93 Case No.:54/26/82­ALC4/2011 Party Name:SHIVA PHARMACHEM LTD, 20.12.2011 Status:Case Approved HQ File :01/82/050/00737/AM12/ RLA File :34/24/040/00096/AM12/ Lic.No/Date:3410031324 19.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals  vide their U.O No. 14010/65/2007 dated 12.10.2011 and in consultation with  technical authority present in meeting,  decided to ratify norms under para 4.7 of HBP :   Item of Export Qty. Item of Import Qty 2­Methoxy  Ethyl  Chloride  Appearance:  Clear colourless liquid Assay: Min.99% 1Kg 2­Methoxy  Ethanol  Appearance: Clear  colourless  liquid  Assay: Min.99% 0.890 kg     94 Case No.:67/26/82­ALC4/2011 Party Name:LUPIN LIMITED 20.12.2011 Status:Case Deferred

HQ File :01/82/050/00750/AM12/ RLA File :03/95/040/00384/AM12/ Lic.No/Date:0310649476 19.08.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of Pharmaceuticals.   A copy of application to be sent to Department of Pharmaceuticals.   95 Case No.:29/26/82­ALC4/2011 Party Name:CENTURY PHARMACEUTICALS LTD. 20.12.2011 Status:Case Approved HQ File :01/82/050/00712/AM12/ RLA File :34/24/040/00102/AM12/ Lic.No/Date:3410031337 23.08.2011 Defer Date: Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  earlier  decision  taken  in  Meeting  No.  36/82­ALC4/2011  dated  6.12.2011  and  in consultation with technical authority present in meeting,   decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:­   Export product Exp. Qty. Sl.No. Import items Qty. allowed Imino Ether 1 kg.  1. Erythromycin 1.48 kg     96 Case No.:47/26/82­ALC4/2011 Party Name:ADCOCK INGRAM LTD, 20.12.2011 Status:Case Deferred HQ File :01/82/050/00730/AM12/ RLA File :07/24/040/00204/AM12/ Lic.No/Date:0710081689 23.08.2011 Defer Date:24.01.2012   97 Case No.:64/26/82­ALC4/2011 Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00747/AM12/ RLA File :03/95/040/00396/AM12/ Lic.No/Date:0310649795 23.08.2011 Defer Date:24.01.2012   98 Case No.:1/38/82­ALC4/2011 Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 20.12.2011 Status:Case Deferred HQ File :01/82/050/00987/AM12/ RLA File :05/24/040/00246/AM12/ Lic.No/Date:0510306115 20.10.2011 Defer Date:24.01.2012

99 Case No.:1/34/82­ALC4/2011 Party Name:YASHO INDUSTRIES PVT.LTD.   20.12.2011 Status:Case Approved HQ File :01/82/050/00926/AM12/ RLA File :03/95/040/00632/AM12/ Lic.No/Date:0310663844 08.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals & Petrochemicals vide their U.O No. 14010/95/2011/Ch.­II dated 22.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP   Item of Export Qty. Item of Import Qty. Copper Dibutyl Dithiocarbamate (CDBC) 1Kg Di­N­Butylamine (Dibutylamine) 0.600 kg     100 Case No.:3/34/82­ALC4/2011 Party Name:YASHO INDUSTRIES PVT.LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00957/AM12/ RLA File :03/95/040/00668/AM12/ Lic.No/Date:0310665924 18.11.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC.   101 Case No.:2/38/82­ALC4/2011 Party Name:FDC LTD 20.12.2011 Status:Case Deferred HQ File :01/82/050/00988/AM12/ RLA File :03/94/040/00700/AM12/ Lic.No/Date:0310669242 07.12.2011 Defer Date:24.01.2012 Decision : The Committee decided to call from the firm percentage of API in the Export Production from the firm and deferred the case for 24.01.2012.   102 Case No.:3/38/82­ALC4/2011 Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 20.12.2011 Status:Case Approved HQ File :01/82/050/00989/AM12/ RLA File :31/83/040/00184/AM12/ Lic.No/Date:3110051790 08.12.2011   Decision:   Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals & Petrochemicals vide their U.O No. 14010/11/2009/Ch.­II dated 17.6.2010 and in consultation with technical authority present in meeting  decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:­         Export Product Quantity Item of Import Quantity (Kilogram)

Trigonox­C Tert.butyl peroxy benzonate 1Kg. Tert butyl hydro peroxide 70% 0.720 kg     Benzoyl Chloride (BOCI) 0.765 kg     Magnesium Sulphate 0.026 kg     103 Case No.:4/38/82­ALC4/2011 Party Name:YASHO INDUSTRIES PVT.LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00990/AM12/ RLA File :03/95/040/00723/AM12/ Lic.No/Date:0310669658 09.12.2011 Defer Date:24.01.2012   104 Case No.:5/38/82­ALC4/2011 Party Name:YASHO INDUSTRIES PVT.LTD. 20.12.2011 Status:Case Deferred HQ File :01/82/050/00991/AM12/ RLA File :03/95/040/00729/AM12/ Lic.No/Date:0310669660 09.12.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC.   105 Case No.:6/38/82­ALC4/2011 Party Name:INDO GERMAN ALKALOIDS 20.12.2011 Status:Case Deferred HQ File :01/82/050/00992/AM12/ RLA File :03/94/040/00776/AM12/ Lic.No/Date:0310669794 09.12.2011 Defer Date:24.01.2012 Decision : The Committee deferred the case for 24.01.2012 for comments of Department of C&PC. Date:26.12.2011 Place:New Delhi Lalita Maini Foreign Trade Development Officer